FDA Panel Unanimously Recommends Authorization of Moderna COVID-19 Vaccine Booster

A Food and Drug Administration (FDA) advisory panel voted unanimously on Thursday to recommend the agency let millions of Americans get a booster of Moderna’s COVID-19 vaccine.

The 19–0 vote came after hours of discussions and presentations in an all-virtual meeting.

Moderna officials presented data from clinical trials, including a small trial that studied the safety and effectiveness of a booster, as did officials from Israel, one of the first countries in the world to start giving boosters, and the FDA, which performed an analysis of Moderna’s data but did not support or oppose the company’s application for an emergency use authorization expansion.

The FDA can overrule the panel’s recommendations but rarely do so. If the recommendations are approved, everybody 65 and older will be able to get a Moderna booster if they received a primary Moderna series. So will people between the ages of 18–64 deemed “at high risk of severe COVID-19” or whose “frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19.”

SARS-CoV-2 is another name for the CCP (Chinese Communist Party) virus, which causes COVID-19.

The boosters would be a 50 microgram dose for people six or more months after they received their second dose, which is itself typically administered one month after the initial jab.

The primary two-dose series is 100 micrograms each.

Moderna said its small trial, consisting of just 171 people who got the regular primary series and a half-dose booster, showed a smaller amount could still bolster protection against CCP virus infection.

Officials discussed how data from other trials signal the vaccine is still holding up well against severe disease but that there’s been plummeting effectiveness against infection, particularly after the Delta variant became dominant in the United States.

Some panel members struck a skeptical tone on widespread boosters, pointing to the small number of people who got another shot and were studied and highlighting how some populations, including young, healthy people, don’t seem to need another shot.

“I’m not wild about a bunch of 20-year-olds going out and getting a booster dose, unless they’re at increased risk of either exposure or severe outcome,” Dr. Mark Sawyer, professor of clinical pediatrics at the University of California, San Diego School of Medicine and a temporary panel voting member, said before the vote.

The Centers for Disease Control and Prevention advisory panel will ultimately make the decision on who should get a Moderna booster, Sawyer noted, though it’s in danger of being overruled by the agency’s head, as happened with Pfizer’s additional shot.

There was discussion about amending the third piece of the recommendation but a number of members brushed aside the talk, in part because of a desire to match with the recommendation the same panel gave for a booster for Pfizer’s COVID-19 vaccine last month, and nobody ended up dissenting.

“We already approved it for Pfizer. I don’t see how we can possibly not approve it for Moderna and not have most U.S. folks be completely confused. I know that’s not part of what we’re supposed to think about, but I think it’s a pragmatic issue,” said Dr. Stanley Perlman, a temporary voting member and a professor in the University of Iowa’s Departments of Microbiology and Immunology.

Dr. Cody Meissner, a professor of pediatrics at the Tufts University School of Medicine and a panel member, twice asked for evidence that people can be at high risk for serious complications based on their work. Dr. Dorian Fink, an FDA official, said that there was no “specific data” but that there’s concern about so-called long COVID, or alleged problems that stem from COVID-19 and are seen even after somebody stops testing positive for the disease.

Meissner ended up endorsing the recommendations. But he warned the panel against voting for evidence-free language.

“If we can’t defend these recommendations based on evidence, it’s going to further complicate getting this vaccine into every single adult American, and that’s really what we want to do,” Meissner said.

Dr. James Hildreth, president and CEO of Meharry Medical College and a temporary voting member (pdf), challenged Meissner, saying the only evidence he needed for the occupational risk advice was that minorities are more likely to have underlying conditions, putting them at higher risk of severe cases of COVID-19.

Perlman said that the piece was important because the United States cannot afford to have healthcare workers even test positive for COVID-19, because that means they’ll have to miss work even if they’re not showing symptoms.

Many spoke in favor of advising the FDA to widen the emergency use authorization again, after previously letting people with weak immune systems get a third jab. They said the fact that the Pfizer and Moderna vaccines are similar means that data regarding Pfizer boosters, including virtually all the information from Israel, informed their decision, as did the millions of Americans who have already gotten the third shot.

“We need boosters in some populations,” Sawyer said.

Dr. Patrick Moore, a temporary voting member and a professor at the University of Pittsburgh Cancer Institute, said his vote was based on “more of a gut feeling” than serious data. “The data itself is not strong but it is certainly going in a direction that is supportable of this vote,” he added.

Panel members are set to meet again Friday to consider whether to advise the FDA to expand authorization for Johnson & Johnson’s vaccine.

From The Epoch Times